Control of design and development changes of ISO 13485
Control of design and development changes of ISO 13485
Clause 7.3.7
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
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